Heart FailureNCT05057364
Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure
A study testing Heart Smart Virtual Self-Management Group in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Smart Virtual Self-Management Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure
- Receiving home health care from Penn Medicine at Home at time of screening.
- Technology capabilities to participate in the program (laptop or tablet with a camera, internet access).
- Able to read and write in English.
- Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test.
Who cannot join
- Hearing impairment that impacts communication.
- Previous experience receiving occupational therapy services from the principal investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine at Home
Bala-Cynwyd, Pennsylvania, 19004
About this study
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.
Read the detailed description
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure. Heart Smart will provide synchronous virtual group education to homebound people with heart failure receiving services from Penn Medicine at Home. The primary clinical goal is to improve self-efficacy for heart failure self-management and improve their knowledge of heart failure self-management strategies. Secondary outcomes will explore the feasibility of the program by exploring technology, adherence and satisfaction with the program.
- Conditions
- Heart Failure
- Being tested
- Heart Smart Virtual Self-Management Group
- Keywords
- Heart failure, telehealth, occupational therapy, self-management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Smart Virtual Self-Management GroupOther
The Heart Smart Intervention is a 6 week virtual program consisting of one individual technology training session followed by 5 one hour group education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Heart Smart Group | Experimental | Receives Heart Smart Intervention Receives: Other: Heart Smart Virtual Self-Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
This self-report scale has 6 items which are each rated on a scale of 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the scores for the six items. Possible scores are 1-10 with higher scores indicating higher self-efficacy. This scale is an appropriate outcome measure for a heart failure self-management group because it was designed to measure self-efficacy in people with chronic conditions such as heart failure and has undergone psychometric evaluation. This scale is free to use without permission. Administration takes less than 10 minutes.
Measured: At first and final sessions (weeks 1 and 6)
Secondary outcomes (2)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
This 23-item, Likert scale, self-report heart failure specific outcome measure. The instrument measures six domains: physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. This instrument is appropriate because it is designed for use for people with heart failure, will give an indication of participant heart failure severity for demographic purposes, and has a validated self-efficacy component. This scale requires a license which has been obtained for this pilot project. Administration takes less than 10 minutes. Scores range from 0 to 100 with higher scores indicating higher cardiac health status.
Measured: At first and final sessions (weeks 1 and 6)
Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
This 30 item multiple choice measure of heart failure self-management knowledge yields scores 0-30 which are commonly reported as a percentage (higher scores indicate more knowledge). Content validity was established through a panel of expert heart failure nurses.
Measured: At first and final sessions (weeks 1 and 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start28 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study, single group, no control. pre-post data collection
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Frye, MS OTR/L ATP, University of Pennsylvania
- Investigators
- Sara Frye, MS OTR/L ATP, Principal investigator, Penn Medicine at Home Professional Development Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057364
- Sponsor's protocol ID
- 849646
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butler J, Khan MS, Mori C, Filippatos GS, Ponikowski P, Comin-Colet J, Roubert B, Spertus JA, Anker SD. Minimal clinically important difference in quality of life scores for patients with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Jun;22(6):999-1005. doi: 10.1002/ejhf.1810. Epub 2020 Apr 2.
PubMed 32239794Butts B, Higgins M, Dunbar S, Reilly C. The Third Time's a Charm: Psychometric Testing and Update of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2018 Jan/Feb;33(1):13-21. doi: 10.1097/JCN.0000000000000413.
PubMed 28481824Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
PubMed 10758967Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
PubMed 12867348Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
PubMed 11769298Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
PubMed 25091546Spertus JA, Jones PG, Kim J, Globe D. Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients. Qual Life Res. 2008 Mar;17(2):291-8. doi: 10.1007/s11136-007-9302-5. Epub 2007 Dec 29.
PubMed 18165909
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure
- ClinicalTrials.gov ID
- NCT05057364
- Acronym / sponsor ID
- 849646
- Conditions
- Heart Failure
- Keywords
- Heart failure, telehealth, occupational therapy, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure.
Detailed description
The purpose of this capstone project is to pilot Heart Smart, a virtual group program to improve self-efficacy for self-management skills for homebound people with heart failure. Heart Smart will provide synchronous virtual group education to homebound people with heart failure receiving services from Penn Medicine at Home. The primary clinical goal is to improve self-efficacy for heart failure self-management and improve their knowledge of heart failure self-management strategies. Secondary outcomes will explore the feasibility of the program by exploring technology, adherence and satisfaction with the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study, single group, no control. pre-post data collection
| Arm | Type | Receives |
|---|---|---|
| Heart Smart Group | Experimental | Other: Heart Smart Virtual Self-Management GroupReceives Heart Smart Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of heart failure
- Receiving home health care from Penn Medicine at Home at time of screening.
- Technology capabilities to participate in the program (laptop or tablet with a camera, internet access).
- Able to read and write in English.
- Cognitive ability to participate in the program if the participant is able to score12/15 on the Montreal Cognitive Assessment (MoCA) 5 Minute Phone Test.
Key exclusion criteria (2 listed)
- Hearing impairment that impacts communication.
- Previous experience receiving occupational therapy services from the principal investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Smart Virtual Self-Management GroupThe Heart Smart Intervention is a 6 week virtual program consisting of one individual technology training session followed by 5 one hour group education sessions. | Other | Heart Smart Group |
Primary outcome
Change in Self-Efficacy Measure for Chronic Disease (SEMCD)
Time frame: At first and final sessions (weeks 1 and 6)
This self-report scale has 6 items which are each rated on a scale of 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the scores for the six items. Possible scores are 1-10 with higher scores indicating higher self-efficacy. This scale is an appropriate outcome measure for a heart failure self-management group because it was designed to measure self-efficacy in people with chronic conditions such as heart failure and has undergone psychometric evaluation. This scale is free to use without permission. Administration takes less than 10 minutes.
2 secondary outcomes
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: At first and final sessions (weeks 1 and 6)
Change in Atlanta Heart Failure Knowledge Test V3 (AHFKT)
Time frame: At first and final sessions (weeks 1 and 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 32239794Butler J, Khan MS, Mori C, Filippatos GS, Ponikowski P, Comin-Colet J, Roubert B, Spertus JA, Anker SD. Minimal clinically important difference in quality of life scores for patients with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Jun;22(6):999-1005. doi: 10.1002/ejhf.1810. Epub 2020 Apr 2.
- Background: PubMed 28481824Butts B, Higgins M, Dunbar S, Reilly C. The Third Time's a Charm: Psychometric Testing and Update of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2018 Jan/Feb;33(1):13-21. doi: 10.1097/JCN.0000000000000413.
- Background: PubMed 10758967Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.
- Background: PubMed 12867348Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Background: PubMed 11769298Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
- Background: PubMed 25091546Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
- Background: PubMed 18165909Spertus JA, Jones PG, Kim J, Globe D. Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients. Qual Life Res. 2008 Mar;17(2):291-8. doi: 10.1007/s11136-007-9302-5. Epub 2007 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Frye, MS OTR/L ATP principal investigator
Penn Medicine at Home Professional Development Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Smart Virtual Self-Management Group in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Efficacy Measure for Chronic Disease (SEMCD) (time frame: At first and final sessions (weeks 1 and 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057364, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.